No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Healthy Volunteers Welcome
You do not need to have the condition being studied to take part.
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Review the details below, then apply to join this clinical trial.
At a Glance
Age
4 – 8
Sex
Any
Study type
Interventional
Purpose
Supportive Care
Participants needed
225 (estimated)
Sponsor
University of North Carolina, Chapel Hill · Other
Who this trial is looking for
This trial is looking for children aged 4 to 8 who are anxious about dental visits. Participants will receive a dental exam with or without the presence of a therapy dog, and their stress levels will be measured.
Are You a Good Fit for This Trial?
You may be able to join if
I am between 4 and 8 years old.
I speak English.
I haven't had a dental cleaning or exam in the past 3 months.
I am in stable physical health.
I can understand what is expected of me in the study.
I have signed an assent form and my legal guardian has given consent.
You may not be able to join if
I am under 4 years old or over 8 years old.
I do not speak English.
I do not want to participate or my parent/guardian did not give consent.
I have current dental pain.
I have allergies or bad reactions to dogs or dental products.
I am afraid of dogs or have had a bad experience with dogs.
I have a serious medical or psychiatric condition that could affect my participation.
I have a developmental or cognitive disability that prevents me from understanding the study.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
A prospective randomized trial measuring physiologic biometrics and perceptions of stress during a pediatric dental exam, cleaning, and simulated radiographs with or without a therapy dog present.
Trial Locations
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Eligibility Criteria
Inclusion Criteria: Subjects must meet all of the following inclusion criteria to be eligible for enrollment in the study:
* 4-8 years of age
* English speaking
* Qualifies for a dental exam and prophylaxis (cleaning) by having not received a dental prophylaxis or oral exam in the past 3 months
* S…
Inclusion Criteria: Subjects must meet all of the following inclusion criteria to be eligible for enrollment in the study:
* 4-8 years of age
* English speaking
* Qualifies for a dental exam and prophylaxis (cleaning) by having not received a dental prophylaxis or oral exam in the past 3 months
* Stable physical health, decided at the discretion of the study coordinator and PI
* Able to comprehend and follow the requirements of the study (including availability on scheduled visit dates) based on research site personnel's assessment
* Evidence of a personally signed and dated informed assent form from the child and legal guardian's consent document indicating the subject (or legally acceptable representative) has been informed of all pertinent aspects of the trial and all of their questions have been answered
Exclusion Criteria: Subjects presenting with any of the following will not be included in the study:
* Patients \<4yo and \>8yo
* Non-English speakers
* Patients unwilling to assent/participate or parental/guardian consent was not given
* Self-report or parental report of patient suffering current dental pain
* Known allergies or significant adverse reactions following exposure to dogs or the use of oral hygiene products (toothpastes, mouth rinses), and all ingredients in prophy paste
* Children who are afraid of dogs or had a prior negative experience with dogs as reported by the parent or child
* Severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with trial participation or may interfere with the interpretation of trial results and, in the judgment of the Investigator, would make the subject inappropriate for entry into this trial
* Developmental/cognitive disability such that patient cannot self-assent, comprehend and follow the requirements of the study based on research site personnel's assessment
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